Proposal for a new Swedish product liability act – what does it mean?

The existing regulations on product liability for consumer protection were designed way before the current digital environment came into being. To align the regulations with the digital era, new rules are on their way. In this article, Setterwalls summarises some of the implications these changes may have on the Life Sciences sector.

In October 2025, the Swedish Ministry of Justice proposed a new Product Liability Act (replacing the current act dating from 1992) to implement Directive (EU) 2024/2853 on liability for defective products. The Directive, adopted to modernise EU’s liability regime for the digital age should be adopted by Member States to apply to products placed on the market or put into service from 9 December 2026.

The proposal aligns Swedish law to the Directive’s expanded definition of “product,” covering both stand‑alone software (including AI systems) and integrated software, as well as digital manufacturing files (i.e. digital files containing the information necessary for a product to be manufactured using automated machines or tools). In the Life Sciences sector, this affects not only software‑as‑a‑medical‑device, but also connected medical devices, digital therapeutics and other data‑driven solutions.

The proposal also mirrors the Directive’s safety assessment. A product is defective if it does not provide the safety that the public is entitled to reasonably expect. New assessment criteria require that account be taken of foreseeable interactions in connected environments (e.g. smart devices), the product’s capacity to learn or acquire new properties post‑market release and whether a product intended to prevent harm (e.g. certain medical devices) fulfils that safety purpose. Importantly, the mere availability of a “better” version or an update does not, by itself, render earlier versions unsafe.

While the assessment of whether a product is defective should generally be made taking into account the conditions that prevailed when the product was placed on the market or put into service – where a manufacturer retains control after market release – by modifying the product or retaining the ability to provide software updates or upgrades, the safety assessment is instead made on the basis of when that control ceases, expanding responsibility into the product’s operational life.

In addition to manufacturers and importers, the proposal extends primary liability to EU‑established authorised representatives, as well as distribution service providers where the manufacturer is outside the EEA and no importer or authorised representative is available.  Distributors and certain online platform providers may bear secondary liability for “anonymous” products unless they promptly identify an EEA‑established liable economic operator, or for online platform providers, if it is clear from the online platform that the provider is only acting as an intermediary for the contract.

While claimants must prove defect, damage and causation, the inquiry proposes significant presumptions that ease the burden of proof for the injured party. A safety defect can inter alia be presumed if a court-ordered disclosure is not complied with, if mandatory safety requirements are breached, or in the case of an obvious malfunction in normal use. Causation between the defect and damage may inter alia be presumed where the harm typically aligns with the defect.

As under the 1992 Act, strict liability applies, with compensation for personal injury and damage to property not used exclusively for professional purposes. New to the report’s proposal is that damage to data used exclusively for personal purposes may also be subject to compensation.

The standard statute of limitations of a three‑year period from knowledge of the damage, defect and liable party is retained. As under the 1992 Act, claims for damages must also be brought within ten years of market release or of the product being put into service; or, for substantially modified products, from the time of modification. However, a novel provision in Swedish law is the introduction of a 25‑year long‑stop for latent personal injuries where the injured party has been prevented from bringing an action in time due to the nature of the damage.

The report recommends entry into force on 9 December 2026.  The 1992 Act would continue to apply to products placed on the market or put into service before that date.

If adopted as proposed, the new Act would deliver a framework aligned with modern technological advancements that strengthen claimant protection. Setterwalls will closely monitor developments and can assist with questions regarding the proposal or liability legislation in general. Please do not hesitate to contact us.